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Completed

NCT Number: NCT02457871

Promoting Self-Management in Low Income African Americans Living With Hypertension

The specific study aims are to: 1) examine differences between an Ecological Nursing Case Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Milwaukee College of Nursing

Milwaukee, Wisconsin, 53201, United States

About this study

Health outcomes of chronically ill low-income adults are costly in both fiscal and human terms. Although advances have been made in understanding how nurse case management (NCM) can contribute to self-management (SM) behaviors, the factors that contribute to sustained SM behaviors in low-income African American populations are not well understood. This study will examine the impact of Ecological Nurse Case Management (ENCM) on self-management behaviors, health status, and self-efficacy of poor, chronically ill, African American adults. In addition, we will explore moderating effects to determine if the ENCM intervention is differentially effective based on gender or perceived stress. The study will use the UWM Automated Community Health Information System, a relational electronic health record, to document the individualized ECNM intervention and dose of the intervention. The specific study aims are to: 1) examine differences between an ENCM treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention. Acknowledging the small sample size, mixed models for repeated measures data (at baseline and M1, 3, and 6 post-intervention) will be fit to interactions involving moderating variables of gender and stress. The ENCM intervention draws on evidence that given the proper tools (i.e., knowledge, skills and support), individuals can learn to better self-manage their symptoms on a day to day basis and better utilize the health care resources available to them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypertension diagnosis Attend Bread of Healing Clinic

Exclusion criteria

  • No Hypertension diagnosis Do not Attend Bread of Healing Clinic

Treatment and study plan

Ecological Nurse Case Management

Behavioral

The Ecological Nurse Case Management (ENCM) intervention allows for individualized case management based on client preferences through mutual goal setting and client choice points, nursing assessments, the nurse's analytic decision-making process and critical thinking, and nursing actions.

Primary outcomes

  1. Change measures

    Time frame: @ baseline,one month, three months, six months

    NIH Toolbox Perceived Stress Survey NIH Toolbox Self-efficacy Survey Hypertension Self-Care Profile Blood pressure, BMI and Waist Circumference changes Hypertension Self-Care Profile

Secondary outcomes

  1. Automated Community Health Information System (ACHIS) data elements

    Time frame: 6 months

    Data elements of ACHIS, including Omaha System informatics codes, will be used to measure the intervention dose and intervention outcomes of nurse rated knowledge and client self-reported health status.

Sponsors and collaborators

Lead sponsor

Bev Zabler

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Acronym: ENCM

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 29, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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